Abstract

INTRODUCTION The treatment of COVID-19 is still challenge. So convalescent plasma can be an important alternative of treatment. Protocols with nursing care during infusion is very important to guide an effective and safety care. OBJECTIVE to analyze the evidence in the literature on the action of convalescent plasma, of the use of protocols with nursing care to use convalescent plasma and build a nursing care protocol for transfusion in patients with COVID-19. METHODS Methodological study carried out in two stages: scoping review. The search was done using the descriptors: convalescent plasma transfusion, convalescent plasma, and acute respiratory syndromes or COVID-19, to found protocols and effectiveness of convalescent plasm. Beside was done a specialist panel to build the protocol. RESULTS Low-evidence studies have shown improvement in the clinical signs of COVID-19 using Convalescent Plasma, reduction or elimination of viral load, benefits in the production of lymphocytes, decreases C-reactive protein, increases titers of anti-SARS-CoV-2 antibodies, positive evolution in lung involvement identified by X-rays, decrease in hospitalization. No studies were found in the databases on the protocol for clinical nursing care in plasma transfusion. Therefore, a protocol was developed with the description of clinical nursing care to be performed before, during and after the transfusion by plasma: checking of vital signs and indicative signs of transfusion reaction, measurement of oxygen saturation, assessment of venous access and checking of the level of consciousness. CONCLUSION There are no evidence studies to support the use of plasma, nor anything related to bundles.

Abstract

BACKGROUND The coronavirus disease 2019 (COVID-19) has outbroken into a global pandemic. The death rate for hospital patients varied between 11% and 15%. Although COVID-19 is extremely contagious and has a high fatality rate, the amount of knowledge available in the published literature and public sources is rapidly growing. The efficacy of convalescent plasma (CP) therapy for COVID-19 is controversial. OBJECTIVE This meta-analysis was designed to assess the efficacy of CP therapy for COVID-19 through a literature survey. METHODS Until August 30, 2021, a literature search was undertaken in Pubmed, Embase, Web of Science, Cochrane Central Register of Controlling Trials (Central), and China National Knowledge Infrastructure databases. The Risk Ratio (RR) and 95% confidence intervals (CIs) were pooled using a fixed or random effect model in dichotomous data. Mean difference (MD) and 95% confidence intervals (CIs) were pooled using a fixed or random effect model in continuous data. Studies with missing or unsuitable data were presented descriptively in the outcomes. RESULTS In total, thirteen randomized controlled trials (RCTs) were selected for the present meta-analysis, which included a total of 13232 participants. Our results revealed that the CP group has lower mortality compared to the control group, and there was a statistically significant difference (RR: 0.70, 95% CI: 0.55, 0.89, Z = 2.92, P = 0.004 < 0.01); other secondary outcomes such as the shortness of breath symptom improved significantly in CP group (RR:1.48, 95% CI: 1.13, 1.93, Z = 2.85, P = 0.004 < 0.01), as well as Interleukin-6 (IL-6) (MD: -4.46, 95% CI: -8.28, -0.63, Z = 2.28, P = 0.02 < 0.05) and Ferritin (MD: -447.68, 95% CI: -501.75, -393.6, Z = 16.23, P < 0.00001) are reduced significantly in CP group. However, there was no statistically significant change in the ventilator withdrawal rate, imaging results improvement, or days to hospital discharge. There was also no substantial difference in viral nucleic acid negative conversion rate and neutralizing antibody-positive conversion rate, as well as the incidence of adverse reactions. CONCLUSIONS The safety and potential efficacy of convalescent plasma therapy offer a promising treatment strategy for COVID-19. CP therapy can reduce mortality and improve breath and inflammatory cytokines IL-6 and Ferritin in COVID-19 with no significant increase in adverse reactions. However, it does not affect improving virology indicators. In summary, more high-quality clinical trials are needed to verify the conclusion of the present study.

Abstract

IMPORTANCE COVID-19 convalescent plasma (CCP) is a potentially beneficial treatment for COVID-19 that requires rigorous testing. OBJECTIVE To compile individual patient data from randomized clinical trials of CCP and to monitor the data until completion or until accumulated evidence enables reliable conclusions regarding the clinical outcomes associated with CCP. DATA SOURCES From May to August 2020, a systematic search was performed for trials of CCP in the literature, clinical trial registry sites, and medRxiv. Domain experts at local, national, and international organizations were consulted regularly. STUDY SELECTION Eligible trials enrolled hospitalized patients with confirmed COVID-19, not receiving mechanical ventilation, and randomized them to CCP or control. The administered CCP was required to have measurable antibodies assessed locally. DATA EXTRACTION AND SYNTHESIS A minimal data set was submitted regularly via a secure portal, analyzed using a prespecified bayesian statistical plan, and reviewed frequently by a collective data and safety monitoring board. MAIN OUTCOMES AND MEASURES Prespecified coprimary end points-the World Health Organization (WHO) 11-point ordinal scale analyzed using a proportional odds model and a binary indicator of WHO score of 7 or higher capturing the most severe outcomes including mechanical ventilation through death and analyzed using a logistic model-were assessed clinically at 14 days after randomization. RESULTS Eight international trials collectively enrolled 2369 participants (1138 randomized to control and 1231 randomized to CCP). A total of 2341 participants (median [IQR] age, 60 [50-72] years; 845 women [35.7%]) had primary outcome data as of April 2021. The median (IQR) of the ordinal WHO scale was 3 (3-6); the cumulative OR was 0.94 (95% credible interval [CrI], 0.74-1.19; posterior probability of OR <1 of 71%). A total of 352 patients (15%) had WHO score greater than or equal to 7; the OR was 0.94 (95% CrI, 0.69-1.30; posterior probability of OR <1 of 65%). Adjusted for baseline covariates, the ORs for mortality were 0.88 at day 14 (95% CrI, 0.61-1.26; posterior probability of OR <1 of 77%) and 0.85 at day 28 (95% CrI, 0.62-1.18; posterior probability of OR <1 of 84%). Heterogeneity of treatment effect sizes was observed across an array of baseline characteristics. CONCLUSIONS AND RELEVANCE This meta-analysis found no association of CCP with better clinical outcomes for the typical patient. These findings suggest that real-time individual patient data pooling and meta-analysis during a pandemic are feasible, offering a model for future research and providing a rich data resource.

Abstract

This study investigated the efficacy and safety of convalescent plasma (CP) transfusion against the coronavirus disease 2019 (COVID-19) via a systematic review and meta-analysis of randomized controlled trials (RCTs). A total of 5467 articles obtained from electronic databases were assessed; however, only 34 RCTs were eligible after manually screening and eliminating unnecessary studies. The beneficial effect was addressed by assessing the risk ratio (RR) and standardized mean differences (SMDs) of the meta-analysis. It was demonstrated that CP therapy is not effective in improving clinical outcomes, including reducing mortality with an RR of 0.88 [0.76; 1.03] (I(2) = 68% and p = 0.10) and length of hospitalization with SMD of -0.47 [-0.95; 0.00] (I(2) = 99% and p = 0.05). Subgroup analysis provided strong evidence that CP transfusion does not significantly reduce all-cause mortality compared to standard of care (SOC) with an RR of 1.01 [0.99; 1.03] (I(2) = 70% and p = 0.33). In addition, CP was found to be safe for and well-tolerated by COVID-19 patients as was the SOC in healthcare settings. Overall, the results suggest that CP should not be applied outside of randomized trials because of less benefit in improving clinical outcomes for COVID-19 treatment.

Abstract

PURPOSE To assess and compare the relative efficacy and safety of anti-SARS-CoV-2 antibody regimens for COVID-19. METHODS This systematic review and random-effects network meta-analysis was conducted according to PRISMA-NMA. Literature searches were conducted across MEDLINE, EMBASE, PubMed, Web of Science, CENTRAL, and CNKI up to February 20th, 2022. Interventions were ranked using P scores. RESULTS Fifty-five RCTs (N = 45,005) were included in the review. Bamlanivimab + etesevimab (OR 0.13, 95% CI 0.02-0.77) was associated with a significant reduction in mortality compared to standard of care/placebo. Casirivimab + imdevimab reduced mortality (OR 0.67, 95% CI 0.50-0.91) in baseline seronegative patients only. Four different regimens led to a significant decrease in the incidence of hospitalization compared to standard of care/placebo with sotrovimab ranking first in terms of efficacy (OR 0.20, 95% CI 0.08-0.48). No treatment improved incidence of mechanical ventilation, duration of hospital/ICU stay, and time to viral clearance. Convalescent plasma and anti-COVID IVIg both led to a significant increase in adverse events compared to standard of care/placebo, but no treatment increased the odds of serious adverse events. CONCLUSION Anti-SARS-CoV-2 mAbs are safe, and could be effective in improving mortality and incidence of hospitalization. Convalescent plasma and anti-COVID IVIg were not efficacious and could increase odds of adverse events. Future trials should further examine the effect of baseline seronegativity, disease severity, patient risk factors, and SARS-CoV-2 strain variation on the efficacy of these regimes. REGISTRATION PROSPERO-CRD42021289903.

Abstract

Convalescent plasma is a suggested treatment for Coronavirus disease 2019 (Covid-19), but its efficacy is uncertain. We aimed to evaluate whether the use of convalescent plasma is associated with improved clinical outcomes in patients with Covid-19.In this systematic review and meta-analysis, we searched randomized controlled trials investigating the use of convalescent plasma in patients with Covid-19 in Medline, Embase, Web of Science, Cochrane Library, and medRxiv from inception to October 17(th), 2021. Two reviewers independently extracted the data. The primary efficacy outcome was all-cause mortality. The Cochrane Risk of Bias Tool and GRADE (Grading of Recommendations Assessment, Development and Evaluation) method were used. This study was registered with PROSPERO, CRD42021284861. Of the 8874 studies identified in the initial search, sixteen trials comprising 16 317 patients with Covid-19 were included. In the overall population, the all-cause mortality was 23.8% (2025 of 8524) with convalescent plasma and 24.4% (1903 of 7769) with standard of care (risk ratio (RR) 0.97, 95% CI 0.90-1.04) (high-certainty evidence). All-cause mortality did not differ in the subgroups of noncritically ill (21.7% [1288 of 5929] vs. 22.4% [1320 of 5882]) and critically ill (36.9% [518 of 1404] vs. 36.4% [455 of 1247]) patients with Covid-19. The use of convalescent plasma in patients who tested negative for anti-SARS-CoV-2 antibodies at baseline was not associated with significantly improved survival (RR 0.94, 95% CI 0.87-1.02). In the overall study population, initiation of mechanical ventilation (RR 0.97, 95% CI 0.88-1.07), time to clinical improvement (HR 1.09, 95% CI 0.91-1.30), and time to discharge (HR 0.95, 95% CI 0.89-1.02) were similar between the two groups. In patients with Covid-19, treatment with convalescent plasma, as compared with control, was not associated with lower all-cause mortality or improved disease progression, irrespective of disease severity and baseline antibody status. SYSTEMATIC REVIEW REGISTRATION https://www.crd.york.ac.uk/prospero/, identifier PROSPERO (CRD42021284861).

Abstract

BACKGROUND Among all patients infected with coronavirus disease 2019 (COVID-19), the older adult population was the most affected, with 80%-90% of fatalities occurring in this group. The effectiveness of convalescent plasma (CP) in older adults is considerably more restricted than that in adults, resulting in a demand for data on the efficacy of therapeutic CP in older adults. This meta-analysis of updated literature examined the effect of CP in older adults with COVID-19. METHODS Relevant literature was identified from studies indexed in the Cochrane, PubMed, and Google Scholar databases between December 2019 and April 2022. The primary outcome was all-cause mortality. Risk estimates were pooled using a random-effects model. The risk of bias was assessed by regression-based Egger test using the relative risk (RR) and upper and lower confidence intervals (CIs) of the three included studies. RESULTS Among 377 studies identified, three full-text studies that included 1,038 patients met the inclusion criteria. The results of our meta-analysis showed that CP administration lowered the mortality risk in older adults with COVID-19 (RR=0.47; 95% CI, 0.26-0.86; p=0.01; I2=0%, p<0.81). CP therapy was more useful if delivered early in the course of the disease (within 72 hours of onset) and in less severe stages of the disease. Mortality tended to be lower in the high-titer group. CONCLUSIONS CP treatment was significantly associated with a lower risk of mortality in older adults with COVID-19 than in patients not administered CP. The timing of CP administration is critical since earlier treatment after disease onset was associated with a better prognosis.

Abstract

BACKGROUND AND AIMS The safety and efficacy of convalescent plasma therapy (CPT) in SARS-CoV-2 is promising but intriguing due to heterogeneity of published studies. We conducted this systematic review and meta-analysis of convalescent plasma use in COVID-19 to identify its safety and efficacy. MATERIAL AND METHODS We comprehensively searched the databases - PubMed, Web of Science, Embase, and the Cochrane Library for journal papers published between December 2019 and January 2021 about the use of CPT in SARS-CoV-2, and performed a meta-analysis using random effects models and assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS Of 1529 records, 11 studies were eligible (five RCTs, two nonrandomized intervention trials, three prospective observational, and one retrospective), and all were conducted in confirmed patients of SARS-CoV-2. Out of the 11 studies, four investigated the effect of CPT on mortality, three on symptom alleviation, five on duration of hospital stay, four on time to discharge, three on the effect on viral clearance, three on the improvement in antibody titers, two on oxygen requirement, and two on adverse events. The pooled estimate for relative risk of death from SARS-CoV-2 was no different after CPT than control (RR: 0.87, 95% CI: 0.69, 1.10), (p = 0.426) but the relative risk of clinical improvement of symptoms was better after CPT (RR: 1.61, 95% CI: 0.97. 2.70). There was earlier hospital discharge after CPT over control (RR: 1.49, 95% CI: 0.79, 2.80), improved viral clearance (RR: 1.95; 95% CI: 1.07, 3.53), and quicker detection of antibody titer (RR: 1.95; 95% CI: 1.07, 3.53). No difference was observed for adverse effects between CPT and control (RR: 0.92.; 95% CI: 0.63 1.35). CONCLUSION CPT appears to be a safe and promising treatment in moderate to severe SARS-CoV-2 leading to faster clinical improvement, reduced oxygen requirement, early hospital discharge, and quicker emergence of protective antibodies despite having no mortality benefit.

Abstract

BACKGROUND Antiviral therapy has a greater impact when provided early in the disease to outpatients, potentially preventing hospitalization and subsequent deaths, while reducing healthcare system pressure. Controversies persist about the best treatment option for COVID-19 outpatients at risk of disease progression to hospital. No head-to-head RCT has been conducted to compare the three major modalities in current use-oral/intravenous antivirals, monoclonal antibodies and COVID-19 convalescent plasma (CCP). METHODS We assembled data from March 2020 to April 2022 from published outpatient RCTs examining authorized COVID-19 therapies with hospitalization as the major endpoint, and that also assessed mortality, symptom resolution, underlying risk factors for progression, timing and dose of the intervention in relationship to evolving variants of concern (VOC). FINDINGS CCP, monoclonal antibodies and oral antivirals each had comparable efficacy converging to 80% hospital risk reduction dependent on the dose and the timing of the intervention. Most RCTs targeted populations with at least one risk factor for severe COVID-19. Control group hospitalizations were less than 10% in 16 of 20 RCTs. Amongst the effective two CCP trials, monoclonals and three antiviral small molecules, deaths were reduced by 90% from 44 total in combined control arm to 4 in intervention arms. The overall risk of bias was deemed low for nine studies and some concerns for eight. The I (2) statistic heterogeneity amongst the outpatient trials with endpoint hospitalization is 72% (p-< 0.01). INTERPRETATION The emerging resistance of Omicron BA.2 and related sublineages (XE, BA.2.12.1, BA.4, and BA.5) to monoclonal antibodies suggests a pressing need to reevaluate CCP (nowadays largely available from vaccinees with high neutralizing antibody levels) for COVID19 outpatients at risk of disease progression, especially in settings with constrained medical resources. FUNDING This study was funded by the US Department of Defense, in collaboration with the Defense Health Agency and NIH. RESEARCH IN CONTEXT Evidence before this study: To date no head-to-head randomized controlled trial (RCT) has ever compared treatment options for COVID-19 outpatients, making comparisons and treatment choices difficult. We assembled RCTs with hospitalization as the primary endpoint. A literature search of MEDLINE (through PubMed), medRxiv and bioRxiv databases was carried out inclusive of RCTs published from March 2020 to April 2022 inclusive, using the search terms ("COVID-19" OR "SARS-CoV-2" OR "coronavirus disease 2019") AND ("treatment" OR "therapy") AND ("outpatient" OR "hospitalization"). The risk of bias obtained at COVID-19-Network Meta-Analysis (NMA), was low in half of the studies with some concerns for the remaining.Added value of this study: This systematic review compared outcomes among RCTs of outpatient therapy for COVID-19, taking into account time between onset of symptoms and treatment administration. We found that small-chemical antivirals, convalescent plasma and anti-Spike monoclonal antibodies had comparable efficacy. Trials of monoclonals were performed prior to the recognition that they had become ineffective against the Omicron sublineages.Implications of all the available evidence: Monoclonal antibodies and small chemical antivirals each have drawbacks. Both take time to be developed and are expensive. Monoclonals can lose efficacy with viral mutation, and chemical antivirals have contraindications and adverse events. Convalescent plasma retains its potency and is likely to be the only accessible therapeutic option for low-and-middle income countries.

Abstract

OBJECTIVE To suggest possible approaches to combatting the impact of the COVID-19 infodemic in-order to prevent research waste in future health emergencies and in everyday research and practice. STUDY DESIGN AND SETTING Systematic review. The Epistemonikos database was searched in June 2021 for systematic reviews on the effectiveness of convalescent plasma for COVID-19. Two reviewers independently screened the retrieved references with disagreements resolved by discussion. Data extraction was completed by one reviewer with a proportion checked by a second. We used AMSTAR-2 to assess the quality of conduct and reporting of included reviews. RESULTS 51 systematic reviews are included with 193 individual studies included within the systematic reviews. There was considerable duplication of effort: multiple reviews were conducted at the same time with inconsistencies in the evidence included. The reviews were of low methodological quality, poorly reported and did not adhere to PRISMA guidance. CONCLUSION Researchers need to conduct, appraise, interpret and disseminate systematic reviews better. All in the research community (researchers, peer-reviewers, journal editors, funders, decision makers, clinicians, journalists and the public) need to work together to facilitate the conduct of robust systematic reviews that are published and communicated in a timely manner, reducing research duplication and waste, increasing transparency and accessibility of all systematic reviews.